Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 14361–14380 of 38,428 recalls
Recalled Item: The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive
The Issue: COVID-19 Interpretive Software issues that may cause: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive
The Issue: COVID-19 Interpretive Software issues that may cause: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Talladium Luminesse Zirconia Discs
The Issue: The linear shrinkage on the zirconia blank disc
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS
The Issue: Measurements done on the Merge PACS generated MPR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Positron Emission Tomography and Computed Tomography System
The Issue: A potential issue of an incorrect CT scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-Ray System
The Issue: A potential issue of an incorrect CT scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-Ray System
The Issue: A potential issue of an incorrect CT scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-Ray System
The Issue: A potential issue of an incorrect CT scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panther Fusion Tube Tray
The Issue: Tube trays may leak which could invalidate patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Padgett Dermatome Set - Product Usage: are intended for
The Issue: lntegra LifeSciences has identified through a number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13 ft Handpiece Cable
The Issue: lntegra LifeSciences has identified through a number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Padgett Electric Dermatome Set - Product Usage: are intended
The Issue: lntegra LifeSciences has identified through a number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris System PC Unit Model 8100 (Pump Module) and
The Issue: Pump Module keypad may exhibit keys that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris System PC Unit Model 8015
The Issue: The pump module keypad may exhibit keys that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris System
The Issue: The Alaris PC unit can display incorrect syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY
The Issue: The pump module keypad may exhibit keys that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris System. The EtCO2 module is a capnograph indicated for continuous
The Issue: Infusion pump component defect may result in interruption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee or Artis Q systems (listed below) - Product
The Issue: exists for the collision supervision not to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and
The Issue: There is a potential for the retaining pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30"
The Issue: The surgical suture is non-sterile. Use could compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.